Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Forrester Pharma (Pty) Ltd, 2 Waterford Mews, Waterford Place, Century City, 7441, Cape Town, South Africa
NUBACAP is indicated for the treatment of adult patients with neuropathic pain due to Herpes zoster infections and diabetes.
The recommended starting dose for NUBACAP is 75 mg twice daily (150 mg/day), with or without food.
Based on individual patient response and tolerability, the dose may be increased to 150 mg twice daily after an interval of 3 to 7 days.
If NUBACAP has to be discontinued, it is recommended this should be done gradually over a minimum of one (1) week.
NUBACAP is eliminated from the systemic circulation primarily by renal excretion as unchanged medicine. As NUBACAP clearance is directly proportional to creatinine clearance (see section 5.2, Special patient groups, Renal impairment), dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 and determined using the following formula:
CLcr (mL/min) = (140 – age) x Wt (kg) / 0,82 x serum creatinine (µmol/L)
* For females multiply the CLcr by 0,85.
NUBACAP is removed effectively from plasma by haemodialysis (50% of NUBACAP in 4 hours). For patients receiving haemodialysis, the NUBACAP daily dose should be adjusted based on renal function. In addition to the daily dose, a supplementary dose should be given immediately following every 4-hour haemodialysis treatment (see Table 1).
Table 1. NUBACAP dosage adjustment based on renal function:
| Creatinine clearance (CLcr) (mL/min) | Total NUBACAP daily dose* | Dose regimen | |
| Starting dose (mg/day) | Maximum dose (mg/day) | ||
| ≥60 | 150 | 300 | Two divided doses |
| 30-60 | 75 | 150 | Once daily or Two divided doses |
| 15-30 | 25-50 | 75 | Once daily or Two divided doses |
| <15 | 25 | 25-50 | Once daily |
| Supplementary dosage following haemodialysis (mg) | |||
| 25 | 50 | Single dose+ | |
* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.
+ Supplementary dose is a single additional dose.
No dosage adjustment is required for patients with hepatic impairment (see section 5.2, Special patient groups, Hepatic impairment).
No dosage adjustment is necessary for elderly patients unless their renal function is compromised (see Table 1).
The safety and effectiveness of NUBACAP in patients below the age of 18 years, with neuropathic pain, have not been established.
NUBACAP is given orally with or without food.
The most commonly reported adverse events observed when NUBACAP was taken in overdose included affective disorder, somnolence, confusion, depression, agitation, restlessness, seizures and coma.
Treatment of NUBACAP overdose should be symptomatic and supportive and may include haemodialysis if necessary (see section 4.2, Patients with renal impairment).
NUBACAP 25: 24 months.
NUBACAP 75: 36 months.
NUBACAP 150: 36 months.
Store at or below 30°C.
Keep the blister strips in the carton until required for use.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
NUBACAP 25, 75 and 150 are packed in blister strips of clear PVC/aluminium and packed into an outer cartons.
Pack size: 10, 14, 56, 60 or 100 capsules.
No special requirements.
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